Human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the United States (Genital HPV infection, CDC).
There are more than 200 different types of HPV, around 40 types of HPV that affect the genital area, and 14 clinically relevant high-risk HPV genotypes. The different types of HPV are given numbers and known as HPV genotypes.
Someone who develops an HPV infection can go years without having any symptoms. Most of the time HPV goes away on its own, other times it can cause genital warts, precancer or cancer.
There are differences not only in the prevalence of the HPV genotypes, but also in the risk of those genotypes to cause cervical cancer.
Almost all cervical cancer can be prevented by HPV vaccination, but vaccination isn’t enough because the vaccine coverage is about half of the young population.
There are two different types of HPV vaccines in the US.
There are three common cervical cancer screening paradigms in the US.
A variety of HPV tests can be used to detect HPV genotypes and determine a woman's risk of developing cervical precancer and cancer.
Persistence of HPV, with one of the hr-HPV genotypes, is necessary for the development of cervical precancer and cancer.
A positive HPV test requires further investigation, and the 2019 American Society for Colposcopy and Cervical Pathology (ASCCP) cervical cancer management guidelines recommend a personalized risk-based management.
As the vaccinated population increases, HPV 16 and 18 are decreasing in prevalence, making it crucial to identify the other high-risk HPV genotypes.
HPV 31 poses a higher risk of precancer as compared to HPV 18. Learn how individually identifying HPV 31 can benefit your patients like Tianna.
Extended genotyping allows for a more precise way to measure your patient’s risk for developing cervical precancer and cancer vs. a pooled, high-risk assay.
There are currently 5 FDA-approved HPV assays – each has a different number of results, based on the different hr-HPV genotypes detected and whether these genotypes are reported as a grouped result or as an individual result.
Only an HPV assay with extended genotyping can individually identify hr-HPV genotypes beyond HPV 16 and 18, including HPV 31, which poses a similar risk for cervical precancer as compared to HPV 18 and should be managed similarly.
Genotype-specific HPV persistence is the most important determinant of cervical cancer risk in women who test HPV-positive, regardless of HPV genotype.
Extended genotyping provides specific, actionable insights on an extended set of HPV genotypes.
Only the BD Onclarity™ HPV Assay provides you with the most comprehensive HPV test results available on the market today. Get the information you need to more precisely assess her risk of cervical cancer.
Not all HPV tests can identify HPV 31. The BD Onclarity™ HPV Assay is the only FDA-approved HPV test that provides an individual result for HPV 31.
Multiple studies conclude that genotype-specific high-risk HPV persistence is the most important determinant of cervical cancer risk in women who test HPV-positive, regardless of HPV genotype.
The unique design of the BD Onclarity™ HPV Assay gives you the detailed and accurate results that you need to enhance your patient's care experience.
The BD Onclarity™ HPV Assay is FDA-approved for the three most common screening paradigms and for extended genotyping, offering the flexibility you need to adapt to changing screening guidelines.
An overview of FDA-approved HPV assays
The BD Onclarity™ HPV Assay was extensively tested among women of different ages, ethnicities, and vaccination status in a prospective, multicenter clinical trial that enrolled more than 33,000 women.
Vulvovaginitis is the most common reason that women visit their primary care providers for a gynecologic-related issue in the US, resulting in 10 million office visits annually.
Vulvovaginitis symptoms can have different causes that require a specific treatment, which makes proper diagnosis critical.
Left untreated, women with vaginitis can develop severe complications such as pelvic inflammatory disease, fertility issues, and adverse pregnancy outcomes.
The subjectivity and lack of sensitivity associated with traditional in-clinic testing leads to ~40% of women failing to receive a proper diagnosis after an initial primary care visit.
Symptom overlap and co-infections may result in incorrect diagnosis and inadequate treatment, leading to recurrent and persistent infections.
Traditional methods do not allow for the differentiation of Candida species. By identifying the species, you can determine the right approach – and avoid creating treatment resistance and recurring vaginitis.
The BD MAX™ Vaginal Panel is a comprehensive diagnostic test that directly detects the 3 most common infectious causes of vaginitis in one test, with one swab.
There are currently 4 FDA-cleared molecular assays that use PCR amplification for the diagnosis of vaginitis and/or bacterial vaginosis.
Vaginitis and STI co-infection is common: 25% of women with BV or VVC also had an STI. BD offers solutions that help provide a comprehensive diagnosis from the start.
With a wide variety of compatible sample types, you have the flexibility to adapt to your patients needs.
BD is committed to supporting physician offices, hospitals and laboratories that utilize the BD MAX™ Vaginal Panel. That’s why we provide the following resources and services to help our customers navigate coverage and reimbursement challenges.
Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV) are the most prevalent non-viral causes of sexually transmitted infections and accounted for ~$1.1 billion in direct medical costs in 2018.
Chlamydia – caused by infection with Chlamydia trachomatis (CT) bacterium – is the most frequently reported bacterial sexually transmitted infection in the United States.
Gonorrhea – caused by infection with Neisseria gonorrhoeae (GC) bacterium – is the second most commonly reported bacterial sexually transmitted infection in the United States.
Trichomoniasis - caused by infection with the parasite Trichomonas vaginalis - is the most prevalent non-viral STI worldwide.
STIs are on the rise and remain a significant public health concern.
Following STI testing guidelines may help identify asymptomatic cases of infection and protect them from the consequences of STIs.
The BD CTGCTV2 assay is a 3-in-1 FDA-cleared test designed to detect the 3 most prevalent non-viral sexually transmitted infections simultaneously and separately.
The BD CTGCTV2 assay can be run on patient- and clinician-collected vaginal swabs*, urine samples, endocervical swabs**, and on liquid-based cytology media (PreservCyt)**, with similar performance.
Vaginitis and STI co-infection is common. Identify it from visit 1, with one swab.
Learn more about our BD Women’s Health solutions
